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FastVal automates the process of gathering system requirements and tracking those requirements throughout the validation project. Users navigate through their system to be validated, and FastVal automatically documents the screens and reports. With certain systems, FastVal can automatically detect and insert validatable objects. Requirements can also be uploaded into FastVal and inserted directly into validation projects.
Once gathered, requirements are inserted into validation deliverables to provide the structure for the primary content of the documents. From the list of requirements, validation engineers create functional requirements. This list of requirements is used to describe the necessary configurations or technical features for how the system meets those requirements in the design specification. It is also used to verify that the system meets those requirements by creating test cases in the test protocol. Requirements are also inserted into the traceability matrix to ensure that all requirements are tested.
In addition, standard business requirements can be automatically included for all validation projects. This means that standard requirements for such regulations as 21 CFR 11, 21 CFR 211, or 21 CFR 820 are included in all of your validation documents, including text for how the system will meet those requirements.
FastVal manages the process of gathering system requirements. This ensures that all necessary requirements are collected and that all requirements have appropriate specifications and corresponding test cases.
Having a standardized approach to gathering system requirements demonstrates control over your validation process. It ensures that your validation projects have a firm foundation. It ensures that you have a standard approach to dealing with specific types of system requirements. This uniform approach to testing provides your Quality department with a high degree of assurance that you have total control over your validation process and can reduce overall time to review and approve validation deliverables.
FastVal includes templates for all validation documents. Validation document content can be configured to your organization’s specific needs and exported to any MS Word document. FastVal can create any validation document your process requires, including: